Ethical Considerations in Human Subjects Research - Lecture 1

Explore ethical considerations in human subjects research through this 56-minute lecture by Dave Wendler from the NIH Clinical Center. Delve into the history of clinical trials, virtues and concerns in research, conflicts of interest, and key ethical principles. Examine the National Commission's work, challenges in balancing benefits and risks, and the primary ethical concerns in human research. Learn about regulations, guidelines, and the eight ethical requirements for conducting research, including collaborative partnership, social value, scientific validity, and fair subject selection. Discuss the importance of informed consent, respect for subjects, and resolving conflicts in research ethics. Analyze the application of these principles to learning healthcare systems and the SUPPORT trial. Gain valuable insights into the complex ethical landscape of clinical and translational research as part of the NIH Clinical and Translational Research Summer Course.

Intro
Clinical Research
The First Clinical Trial?
Virtues
Concerns
Conflicts of Interest
National Commission
Challenges
Benefits and Risks
Primary Ethical Concern
Regulations and Guidelines
Comparison
8 Ethical Requirements
Collaborative Partnership
Social Value
#2: Evaluation
Scientific Validity
Clinical Equipoise
Assessment
Exceptions
Fair Subject Selection
Protection to Access
Favorable Risk-Benefit Ratio.
Independent Review
Informed Consent
Waiver
Incompetent Participants?
Therapeutic Misconception
Respect for Subjects
Resolving Conflicts
Problems
Rebirth of the Integrated Model?
Application to LHC
SUPPORT Trial
Research and/or Care?
Summary